Microbiota, Metabolome and Nutrition: an 'Artificially Intelligent' Way to Personalized Nutrition
Istituto Clinico Humanitas
48 participants
Dec 22, 2021
INTERVENTIONAL
Conditions
Summary
Intervention: (Weeks 1-2, Visit 3-4) - Starting from the second week after the date of consent, patients with IBS will be randomized 1:1 into two groups. The first group (20 patients) will receive one week of a low FODMAP supplemented with fermented milk followed by one week of a low FODMAP content supplemented with fermented beans. The second group (20 patients) will receive a low FODMAP diet supplemented for one week with fermented beans followed by a second week of a diet with a low FODMAP diet supplemented with fermented milk. The microbiome of the patients will be evaluated after the first and second weeks along with data related to weight. After the second week, the metabolome and physical characteristics. The enrollment period will last for one year. The analysis of clinical data will be completed within one year after patient enrollment. Analysis of laboratory data will be performed in parallel.
Eligibility
Inclusion Criteria6
- Patients of both sex and any race
- Age ≥18 and ≤70.
- IBS confirmed by Rome IV diagnostic criteria
- Willing to adhere to the proposed diet
- Provision of written informed consent
- Commitment of availability throughout the study period
Exclusion Criteria8
- Patient age \<18 and \> 70
- Diabetes (Type 1 or 2)
- Subjects who have used probiotic, antibiotic, lactic ferment or pump inhibitors within 15 days prior to screening.
- Pregnant or planning to become pregnant or is lactating.
- History of HIV or hepatitis B or C
- Participation in investigational study within past 30 days
- Unstable cardiovascular or pulmonary disease, with change in treatment in last 30 days due to worsening disease condition
- Any concomitant disease requiring specialized nutrition (e.g. renal failure, celiac disease, cerebrovascular disease of the central nervous system, major surgical cavity)
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Interventions
Dietary restriction of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) have been recently investigated in the management of functional gut symptoms in IBS.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06420843